Incontinence Clinical Trial
Official title:
A Randomized, Controlled Study of the Use of Localized Endorectal Cooling Using the UroCool System During Robotic-Assisted Radical Prostatectomy (RARP) to Minimize Trauma and to Provide Earlier Return to Continence
Localized cooling/hypothermia using the UroCool System during robotic-assisted radical prostatectomy (RARP) surgery results in an improved overall return to continence, (defined as not wearing any protective urinary pads), compared with standard of care in men presenting for RARP.
This study will assess the use of an endorectal cooling device, UroCool, to achieve
controlled, local hypothermia of the pelvis. The study will evaluate the safety and
effectiveness of the device in inducing hypothermia of the neuromuscular tissues impacting
continence during RARP.
The UroCool system is designed to apply targeted temperature control to the pelvic anatomy
during RARP. The pelvis is cooled transrectally via a closed cycle recirculation of chilled
sterile saline using a single-use disposable balloon catheter connected via a circulation IV
set to a control console that is covered by a current 510(k) and commercially available.
The UroCool polymeric catheter is designed to be inserted within the rectal cavity adjacent
to the prostate prior to surgery and removed upon completion of surgery. It is used in
conjunction with the InnerCool Console which circulates cold saline in a closed loop within
the UroCool catheter to allow for therapeutic localized cooling of the prostate gland and
surrounding areas during prostate surgery.
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